Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The DALICATH study aim to demonstrate the non-inferiority of a single administration of 1500 mg of dalbavancin compared with standard documented antibiotic therapy for 14 days according to national guidelines.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Annecy Genevois
• Collaborators: ADVANZ PHARMA; APHP; Centre Hospitalier de Perigueux; Centre National de Reférence des Staphylocoques; French National Network of Clinical Research in Infectious Diseases (RENARCI); Nantes University Hospital
• Treatments: Dalbavancin

Criteria

Inclusion Criteria:

• Patients aged at least 18 years;

• Blood cultures positive for S. aureus, obtained within 72 hours before randomization (the date considered is the date of the sampling, not the results);

• CR-BSI, defined as:

One positive blood culture AND Local signs of infection at the catheter site OR at least one positive blood culture obtained from the catheter and the peripheral vein, AND A differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended AND Same S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures;

• Intravascular catheter - implantable venous access device - removed before randomization;

• Informed consent form date and signed by the patient.

Exclusion Criteria:

• Polymicrobial infection

• More than 72 hours of active antibiotic treatment targeting S. aureus (in-vitro susceptibility) administered prior to randomization;

• Patient with known valvulopathy, previous history of endocarditis, or suspicion of infective endocarditis by physician in charge;

• Suspicion of any other deep focus infections, such as arthritis, pneumonia, osteomyelitis, or meningitis, presence of cerebral or peripheral emboli (arterial occlusion);

• Thrombophlebitis

• Failure to remove any intravascular catheter which was present when first positive blood culture

• Signs of infection associated with quick SOFA score ≥ 2 at randomization

• Patients with foreign bodies such as: prosthetic heart valve, endovascular prosthesis, ventriculo-atrial shunt, pacemaker, or an automated implantable cardioverter defibrillator (AICD) device

• Severe liver disease (Child-Pugh C)

• Severely immunocompromised patients:

• Neutropenia (< 500 neutrophils/µL) at randomization;

• Hematopoietic stem cell transplantation within the past 6 months or planned during treatment period;

• Solid organ transplant;

• Contraindication to dalbavancin and/or glycopeptide

• Life expectancy < 3 months

• Injection drug user

• Pregnant or breastfeeding women

• For premenopausal women: failure to use highly-effective contraceptive methods for 1 month after receiving study drug

• Participation in other interventional trials within the previous three months or ongoing;

• Persons held in an institution by legal or official order;

• Patients under guardianship or curators;

• Patients unable to give a free and informed consent;

• Patient not affiliated to a social security scheme: obligation of affiliation to a social security scheme or to be a beneficiary.